Andrew C. Von Eschenbach M.D.
Food and Drug Administration
Department of Health and Human Services
Field Hearing at the West Madison Agricultural Research Center - Verona, Wisconsin
Committee on Appropriations
Subcommittee on Agriculture, Rural Development, and Related Agencies
Monday March 12, 2007
Good morning, Chairman Kohl. Thank you for the opportunity to appear today to discuss food safety and the safety of fresh produce. I appreciate your commitment to the work of FDA and I commend you for your special interest in the safety of America’s food supply.
Appearing with me today is Dr. Robert Brackett, Director of FDA’s Center for Food Safety and Applied Nutrition. We appreciate the opportunity to discuss FDA’s current processes as well as planned improvements for food safety, particularly the safety of fresh produce.
In the past decade, fresh produce consumption has increased, and fresh-cut produce represents a particularly fast-growing segment of the fresh produce market. These foods are an important part of a healthy and nutritious diet, and Americans expect them to be safe. The 2006 outbreaks of Escherichia coli (E. coli) O157:H7 infection linked to fresh spinach and lettuce emphasize the need for continued efforts to protect the public health from foodborne illnesses associated with fresh produce. We at FDA are committed to doing everything we can to help ensure that these and all other FDA-regulated foods are safe.
Therefore, FDA has requested an increase of $10.6 million for food safety activities in FY 2008. This increase will bring the total FDA investment for food safety to $391million in FY 2008. This investment will help FDA reduce risk across the lifecycle of produce production. FDA will use these resources to develop better methods to detect and attribute foodborne illness outbreaks related to produce, increase sampling and traceback, develop and update guidance to prevent and reduce outbreaks, obtain additional expertise in the production and processing of fresh produce, and enhance our response to foodborne outbreaks.
Fresh vegetables and fruits pose particular food safety challenges. Because most produce is grown in an outdoor environment, it is vulnerable to contamination from pathogens that may be present in the soil, in agricultural or processing water, and in manure used as fertilizer, or due to the presence of animals in or near fields or packing areas. It is also vulnerable to contamination due to inadequate worker health and hygiene protections, environmental conditions, production safeguards, and sanitation of equipment and facilities. The fact that produce is often consumed raw or with only minimal processing, without any type of intervention that would reduce or eliminate pathogens prior to consumption, contributes to its potential as a source of foodborne illness. Consequently, controlling the way fresh produce is grown, harvested, and moved from field to fork is crucial to minimizing the risk of microbial contamination.
For the past 100 years, FDA has established and maintained the gold standard for food safety. Americans have one of the safest food supplies in the world. But the production, distribution, and importation of foods, the public’s consumption practices, and our ability to track and identify foodborne pathogens have changed significantly, and FDA must respond to those changes. Fresh produce serves as a good example of the changes we are witnessing. Consumption of fresh produce – especially items like spinach and lettuce implicated in recent outbreaks of foodborne illness – has increased significantly since 1999. According to USDA, per capita consumption of leafy green lettuce and spinach grew by 59 percent and 130 percent respectively, between 1999 and 2006.
Therefore, reducing the risk of foodborne illness requires strong science capable of identifying both the sources of risk and effective control measures. We are using molecular technology to improve our ability to identify foodborne illnesses and their causes by tracking the fingerprints of the suspected contaminants. We must address some of these risks as food is produced and other risks as food is processed and distributed. We must also enhance our ability to detect and contain outbreaks. Reducing the risk of foodborne illness also requires effective partnerships with other parties interested in food safety. Finally, reducing the risks of foodborne illness also requires FDA to strategically deploy inspection resources in a manner that addresses the greatest risks to the food supply. FDA has focused its food safety efforts in three key areas, and I elaborate on these here.
I. Strengthening the Scientific Basis for FDA’s Program to Improve Food Safety
Strengthening the scientific basis for FDA’s program to improve food safety is key to improving FDA’s effectiveness at protecting public health. For the past decade, FDA has worked closely with USDA’s Agricultural Research Service (ARS) and Cooperative State Research, Education, and Extension Service (CSREES) to coordinate and mutually support our respective research efforts related to produce safety. This relationship allows FDA to augment its research resources and gain access to facilities and expertise we do not have. In this spirit, we collaborated with ARS and CSREES to look for sources of E. coli O157:H7 in California’s Salinas Valley, toanalyze water samples from the Salinas watershed for E. coli O157:H7, and to relate the location of bacteria to geographical, seasonal, or rainfall variation. FDA will use the information obtained from this study to inform produce growers about strategies to prevent pre-harvest microbial contamination.
We strengthen the scientific basis for our program by collaborating and learning with others, such as participating in many scientific and technical meetings on food safety. Last month we participated in a forum sponsored by the Western Institute for Food Safety and Security to share information on assessing industry approaches to address the safety of lettuce and leafy greens on the farm and at packing, cooling, and processing facilities. In February 2007, the FDA-affiliated Joint Institute for Food Safety and Applied Nutrition and the University of Florida sponsored a workshop to improve understanding of how tomatoes become contaminated with Salmonella and other pathogens. In May 2007, FDA, the National Center for Food Safety and Technology, and the University of Georgia’s Center for Food Safety will co-sponsor a workshop on microbial testing to reach a consensus on the role of microbial testing to ensure the safety of produce.
To seek additional input from the public, we are holding two public hearings (March 20 in California and April 13 in Maryland) concerning the safety of fresh produce. We will share information about recent outbreaks of foodborne illness related to fresh produce and solicit comments, data, and other scientific information about current agricultural and manufacturing practices, risk factors for contamination, and possible measures by FDA to enhance the safety of fresh produce.
II. Enhancing Effective Partnerships
To succeed in our science-based efforts to promote food safety, we need to enhance our collaborations with stakeholders interested in food safety, particularly with respect to fresh produce. Fresh produce is produced on tens of thousands of farms, and contamination at one step in the growing and processing chain can be amplified at the next step. FDA has worked with the public and private sector to encourage industry to follow the recommendations and standards contained in FDA guidances. After enlisting the help of the scientific community and the industry, FDA published the “Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables.” This guide, published in 1998, recommends good agricultural practices and good manufacturing practices that growers, packers, and shippers can take to address common risk factors in their operations. We have worked with the domestic and foreign fresh produce industry since the release of this Guide to promote its recommendations and to advance the scientific knowledge to enhance the safety of fresh produce.
The example of fresh sprouts illustrates how successful these efforts can be. In 1999, there were 390 reported illnesses associated with eating contaminated fresh sprouts. FDA published two guidance documents for sprouts that year. We believe that the subsequent decline in sprout-associated illnesses was in large part due to industry adhering to recommendations in those guidances through our outreach and inspection efforts. In 2004, only 33 illnesses were reported associated with fresh sprouts, and in 2005 and 2006 there were none.
FDA’s efforts in this area are ongoing. I am pleased to report that just last week FDA issued a draft final version of its “Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables” (the Fresh-cut Guide). This guidance is intended for all fresh-cut produce firms, including, among others, fresh-cut spinach and lettuce/leafy greens, to enhance the safety of fresh-cut produce by minimizing the microbial food safety hazards. In addition, FDA worked with the Delegation of the United States to the international Codex Alimentarius Commission to request, at the earliest possible date, an expert consultation on the microbiological safety of fresh produce to support the development of commodity-specific annexes to the hygienic code. In August 2006, FDA launched its “Lettuce and Leafy Greens Initiative,” which assesses practices and conditions at select farms and facilities in California, in collaboration with California’s Department of Health Services and its Department of Food and Agriculture. We will continue to work with Federal, state, local and international food safety partners and with industry to develop guidance, conduct research, develop educational outreach materials, and initiate other commodity- or region-specific programs to enhance the safety of fresh produce.
III. Improving Risk-Based Targeting of Inspection Resources
FDA is significantly improving its ability to target its inspection resources at the greatest risks to public health. However, inspections cannot and will not identify every potential contaminant. Improving the processes and operations of all participants in the food production and distribution process offers the greatest protection for American consumers, and inspections are only one component of this activity. To make best use of available resources, FDA uses a targeted, risk-based approach to inspections. FDA conducted 17 percent more import field exams in 2006 than in 2003. In addition, the FDA/USDA Food Emergency Response Network increased its laboratory participation to 134 laboratories in FY 2007, compared to 30 participating laboratories in March 2004 (near FERN's inception), integrating the nation's food testing capability for microbiological, chemical and radiological threat agents.
FDA’s ability to reallocate resources based on risk was tested when peanut butter was recently implicated in an outbreak of Salmonella Tennessee. FDA issued a warning to consumers within 24 hours of receiving notification by CDC, and swiftly deployed inspectors to the plant. ConAgra recalled the products and ceased production in the implicated processing plant. FDA is working to identify the root source of the contamination in order to prevent similar foodborne illness outbreaks from recurring.
FDA is working hard to ensure the safety of food, in collaboration with its Federal, state, local, and international food safety partners, and with industry and all its other stakeholders. The American food supply continues to be among the safest in the world. We have made progress, and we will continue to strive to reduce the incidence of foodborne illness.
Thank you for the opportunity to discuss FDA’s continuing efforts to improve the safety of fresh produce. I am happy to answer any questions.
 Fresh-cut is defined as fruits and vegetables that have been minimally processed and altered in form, by peeling, slicing, chopping, shredding, coring, or trimming, with or without washing or other treatment, prior to being packaged for use by the consumer or a retail establishment. Minimally processed fruits and vegetables have not undergone steps designed to kill pathogens that may be present.
Last revised: April 19, 2011